Complete surveillance for Avastin in Japan

Chugai, the Japanese unit of Swiss drug major Roche, will conduct a complete, all-patient post-marketing surveillance for its anticancer drug Avastin (bevacizumab), which was approved as a treatment for inoperable progressive and recurrent colorectal cancer last month. The investigation will be carried out by 400 cancer specialists who will collect data on patients across 900 medical institutions.

Since Chugai was urged to develop and file a New Drug Application for the drug with the Japanese drug regulator by the Health Ministry's committee on the use of unapproved drugs, the company submitted the NDA based on Phase I clinical data in Japan and the findings of Phase II and III trials overseas and the approval condition is a complete post-marketing surveillance. In Japan, the number of patients with colorectal cancer totaled about 115,000 in 2005.